Protocol summary

Summary
Evidence reveals high incidance of hyperglycemia in NON_DIABETICS undergoing major operations such as cardiac surgery. The aim of this study is to evaluate the effect of INTRA-OPERATIVE glycemic control to preventing hyperglycemia DURING and AFTER cardiac surgery.<br /><br /> Sixty adult non-diabetic patients who undergoing elective coronary artery bypass grafting surgery randomly divided to 2 groups(each group n=30). First group recieved insulin infusion during operation according to a stablished protocol to maintain blood glucose within 110-140 mg/dl. Blood glucose(BG) of patients of second (control) group only monitored every 30 min (such as First group) and recieved bolus insulin only when BG> 250 mg/dl. All patients' BG measured in evry 2 hours after operation until 24h, and every 6h until discharge from ICU. Also postoperative complications recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138705291049N1
Registration date: 2008-09-27, 1387/07/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2008-09-27, 1387/07/06
Registrant information
Name
Rasoul Azarfarin
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
3357310 411 +98
Email address
azarfarinr@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2008-06-21, 1387/04/01
Expected recruitment end date
2009-06-20, 1388/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of blood glucose control with insulin on hyperglycemia during and after coronary artery bypass grafting surgery in non-diabetic patients.
Public title
Blood glucose control with insulin in non-diabetic patients undergoing cardiac operation.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Elective coronary artery bypass grafting surgery, American anesthesiologists Ascociation (ASA) physical status class I and II exclusion criteria : Patients refuse to participate into study, Diabetes mellitus, Taking drugs that affect on blood glucose, Pre-operative unstable hemodynamic or taking inotrop drugs, unexpected event during operation.
Age
From 18 years old to 79 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Regional Ethics committee of Tabriz University of Medical Sciences
Street address
Daneshgah st.
City
Tabriz
Postal code
5166614776
Approval date
2008-06-19, 1387/03/30
Ethics committee reference number
872

Health conditions studied

1

Description of health condition studied
Hyperglycemia in patients undergoing cardiac surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Hyperglycemia
Timepoint
During and early post-operative period
Method of measurement
Blood glucose measurement

Secondary outcomes

1

Description
Post-operative complications (neurologic, infectius, ...)
Timepoint
post-operative period
Method of measurement
Clinical examination

Intervention groups

1

Description
Insulin infusion/no insulin infusion
Category
empty

Recruitment centers

1

Recruitment center
Name of recruitment center
Madani Heart Hospital
Full name of responsible person
Street address
Daneshgah st.
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abdol-hassan Kazemi
Street address
Daneshgah st.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Rasoul Azarfarin
Position
Associate professor in anesthesiology
Other areas of specialty/work
Street address
Madani Heart Hospital, Daneshgah st.
City
Tabriz
Postal code
Phone
+98 41 1336 0894
Fax
Email
azarfarinr@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Rasoul Azarfarin
Position
Associate professor in anesthesiology
Other areas of specialty/work
Street address
Madani Heart Hospital, Daneshgah st.
City
Tabriz
Postal code
Phone
+98 41 1336 0894
Fax
Email
azarfarinr@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Rasoul Azarfarin
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
azarfarinr@tbzmed.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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